Planet Pharma
Senior Specialist, Regulatory Affairs (CMC)
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Direct message the job poster from Planet Pharma
6 month contract
Seattle or Bothell, WA - Candidates should be flexible to work from either the Seattle site, or Bothell site in WA.
This is a hybrid position, candidates are required to be onsite Mondays and Thursdays at either one of those locations.
Duties
Support preparation, review, and submission of CMC sections for U.S. and global regulatory filings, including INDs/CTAs, amendments, and BLAs/MAAs.
Coordinate with internal stakeholders to gather technical information and ensure accuracy and consistency across CMC documentation.
Assist in developing and maintaining submission plans for assigned programs.
Review change controls and manufacturing documentation to assess regulatory impact.
Track and interpret evolving regulatory requirements and guidance relevant to cell and gene therapy manufacturing, testing, and control.
Support interactions with domestic and global health authorities, including preparation of meeting materials, responses to information requests, and briefing documents.
Maintain regulatory databases, document systems, and submission archives in compliance with internal procedures.
Contribute to continuous improvement initiatives within the Regulatory Affairs CMC function.
Skills
3 years of experience supporting Regulatory Affairs and/or CMC functions in the biotechnology industry.
Relevant experience with lentiviral vectors, cell and gene therapy process development and/or analytical method development.
Understanding of FDA regulations and ICH GCP guidelines.
Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and interpersonal skills.
Excellent attention to detail and demonstrated project management skills.
Ability to work independently and collaboratively among cross-functional teams.
Ability to work efficiently, prioritize workflow, meet deadlines, and balance competing priorities.
Education
BA/BSc in a scientific field with a minimum of 5 years’ experience; or
MBA or MSc with a minimum of 2 years’ experience.
#J-18808-Ljbffr
Direct message the job poster from Planet Pharma
6 month contract
Seattle or Bothell, WA - Candidates should be flexible to work from either the Seattle site, or Bothell site in WA.
This is a hybrid position, candidates are required to be onsite Mondays and Thursdays at either one of those locations.
Duties
Support preparation, review, and submission of CMC sections for U.S. and global regulatory filings, including INDs/CTAs, amendments, and BLAs/MAAs.
Coordinate with internal stakeholders to gather technical information and ensure accuracy and consistency across CMC documentation.
Assist in developing and maintaining submission plans for assigned programs.
Review change controls and manufacturing documentation to assess regulatory impact.
Track and interpret evolving regulatory requirements and guidance relevant to cell and gene therapy manufacturing, testing, and control.
Support interactions with domestic and global health authorities, including preparation of meeting materials, responses to information requests, and briefing documents.
Maintain regulatory databases, document systems, and submission archives in compliance with internal procedures.
Contribute to continuous improvement initiatives within the Regulatory Affairs CMC function.
Skills
3 years of experience supporting Regulatory Affairs and/or CMC functions in the biotechnology industry.
Relevant experience with lentiviral vectors, cell and gene therapy process development and/or analytical method development.
Understanding of FDA regulations and ICH GCP guidelines.
Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and interpersonal skills.
Excellent attention to detail and demonstrated project management skills.
Ability to work independently and collaboratively among cross-functional teams.
Ability to work efficiently, prioritize workflow, meet deadlines, and balance competing priorities.
Education
BA/BSc in a scientific field with a minimum of 5 years’ experience; or
MBA or MSc with a minimum of 2 years’ experience.
#J-18808-Ljbffr